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Bimagrumab Study Shows Unexpected Benefits for Diabetes Treatment

A clinical trial that started as an investigation for a treatment of sarcopenia could eventually help treat patients with diabetes and obesity.  

Steven B. Heymsfield, MD, from the Pennington Biomedical Research Center at Louisiana State University, told MD/alert, that during an earlier trial for bimagrumab, they noted the treatment helped patients increase muscle mass as part of its intended goal, but also helped decrease a patient’s body fat, all with very few side effects.  

"That observation is very unusual that you would see something in the human (model) that you didn’t see in the animal model. And they took that observation. They did a very small-scale human study, and they found again that fat mass decreased, muscle mass increased, and that improvement in glucose metabolism insulin resistance also improved markedly," Dr. Heymsfield said.

According to results published in JAMA, the double-masked, placebo-controlled trial lasted 48 weeks. It included 75 patients with type 2 diabetes who had a body mass index between 28 and 40 and glycated hemoglobin levels between 6.5% and 10%.  

Patients enrolled in the trial were treated with either bimagrumab or placebo, both groups also underwent diet and exercise counseling. A total of 58 patients completed the 48-week study period.  

Patients treated with bimagrumab saw a 20.5% reduction in fat mass compared to -0.5% in the placebo group, with a difference in total body fat mass of 7.31 kg. After the 48 weeks, 96% of patients in the bimagrumab arm lost at least 5% of their total body fat mass compared to 10% assigned placebo. 

92% of patients in the drug arm lost at least 10% of their total body fat mass, compared to 10% in the placebo arm, and 77% lost at least 15% of their total body fat mass compared to 10% in the placebo arm.  

The researchers noted that body weight decreased by 6.5% in the drug arm, compared with a decrease of 0.8% with placebo. The reductions in body fat mass and weight differences at 48 weeks were linked to “directionally similar differences” in several categories, including BMI, waist circumference, and waist-to-hip-ratio.  

Heymsfield said so far, the drug appears to be different than anything else on the market today.  

"People have divided weight loss drugs largely into drugs that suppress your appetite and drugs that increase your metabolic rate. And almost all weight loss drugs currently are appetite suppressants, largely appetite suppressants. This drug seems to work by a completely different mechanism. One of those out of the blue kind of observations that it works directly on muscle, and at least the main effect seems to be on muscle. And the fact that you would have an increase in muscle mass at the same time as you lose body fat is totally paradoxical because most people when they go on a diet, lose weight, they lose muscle, and they lose fat."

He said the most common adverse reactions to the treatment were muscle cramps and gastrointestinal effects, but “nothing that anyone would call serious.  

One notable exception, he said, was that some patients experienced an increase in pancreatic enzymes and one case of pancreatitis, which he said the researchers are continuing to study closely.  
 
As someone who has been involved in medical research for many years, Heymsfield said occasionally, a drug being studied for one condition provides benefits for another, but not always to the extent that they found in this trial. 

"This is a very unusual kind of a finding, particularly a strong finding like this where you develop it for one indication, and suddenly you find these effects that lead you down another pathway. It does happen. It’s well known in drug development, but nevertheless, to have an effect that so striking is quite fascinating."

 
By Adam Hochron

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